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The following safety information outlines critical risks and precautions associated with the use of this medication. Carefully review these points and consult your healthcare provider if you have questions or concerns.

• Liver Damage: The combination of pretomanid, Sirturo (bedaquiline), and linezolid (Zyvox) may cause liver damage. This risk is heightened if you have a history of liver issues but can occur in anyone. Regular blood tests will be conducted by your healthcare provider to monitor liver health. Avoid alcohol during treatment and inform your provider about all medications or supplements you're taking. Immediately report symptoms such as fatigue, appetite loss, nausea, vomiting, dark urine, right-side stomach pain, or yellowing of the eyes or skin, as these may indicate liver problems.

• Low Blood Counts: Linezolid (Zyvox), often used with pretomanid and Sirturo (bedaquiline), can lower blood counts, increasing the risk of severe bleeding and infections. Your provider will monitor your blood counts and may adjust medication doses if needed. Seek immediate medical attention for persistent bleeding, infections, or fevers.

• Heart Rhythm Problems: Sirturo (bedaquiline) can affect heart rhythms, potentially leading to QT prolongation, a serious condition. Low blood levels of calcium, magnesium, or potassium can also contribute to this risk. Your provider will perform regular heart scans (EKG) and blood tests to monitor these levels. Inform your provider about your complete medical history, as certain conditions may increase your risk. Seek emergency care if you experience a rapid heartbeat or fainting.

• Nerve and Eye Problems (Peripheral and Optic Neuropathy): The use of pretomanid with Sirturo (bedaquiline) and linezolid (Zyvox) can cause nerve issues, affecting limbs and sometimes eyes. These effects, commonly associated with linezolid, may include numbness, burning sensations, tremors, balance issues, limb weakness, or vision changes. These symptoms are often reversible with dose adjustments. Notify your provider of any such symptoms, and if vision changes occur, an eye specialist consultation may be necessary.

Please ensure you communicate any health changes to your healthcare provider promptly and adhere to their instructions for monitoring and managing potential side effects.

Common side effects:

• nausea
• upset stomach
• diarrhea
• cough
• muscle or joint pain
• acne
• headache
• weakness
• tingling or numbness in the hands and feet
• low red blood cell count (anemia)

Less common but important to monitor:

• higher liver enzymes
• heartburn
• low appetite
• rash
• itchiness
• stomach pain
• sharp chest pain
• respiratory tract infections like bronchitis or pneumonia
• coughing up blood
• vision problems
• low blood sugar
• abnormal weight loss
• constipation
• dry skin
• trouble sleeping

Serious side effects:

• liver damage symptoms (dark urine, right-side stomach pain, yellowing of the eyes or skin, tiredness, loss of appetite, nausea, vomiting)
• unexplained bleeding or bruising
• low white blood cell count leading to repeated fevers or infections
• abnormal heart rhythms like a fast heartbeat or fainting
• serious allergic reaction symptoms (rash, itching or swelling of the face, tongue, or throat, severe dizziness, trouble breathing)